Neuren’s trofinetide engine gains a German boost

DAYBUE growth lifts Neuren income outlook

Neuren Pharmaceuticals (ASX:NEU) has upgraded its expected 2026 income from trofinetide to US$91 million-US$93 million, turning a strong quarter for partner Acadia Pharmaceuticals (Nasdaq:ACAD) into a materially higher royalty outlook. The revised figure includes a US$35 million milestone earned when DAYBUE recorded its first commercial sale in Germany during October.

Acadia reported Q3 DAYBUE net sales of US$140 million, up 39% from the same quarter last year and 12% from Q2. It also raised its full-year global sales guidance to US$505 million-US$520 million, from US$480 million-US$510 million. On that guidance, Neuren expects 2026 royalty income of US$56 million-US$58 million, compared with its previous forecast of US$53 million-US$56 million.

STIX adoption drives quarterly sales momentum

The sales increase was attributed to uptake of DAYBUE STIX among existing patients, as well as new patient starts and restarts. More than half of US DAYBUE users were using STIX by the end of Q3, up from 40% at the end of Q2. The formulation was also identified as a growth driver in the earlier Q2 DAYBUE sales surge, when quarterly net sales reached US$125 million.

“Full year estimates based on Acadia full year 2026 DAYBUE Net Sales Guidance of US$505-520m.”

Neuren earned US$16.4 million in royalty income during Q3, 51% more than in Q3 2025. The company’s income guidance is therefore being supported by both recurring royalties and the one-off European launch milestone, rather than by a change to the underlying licence structure.

German launch opens European royalty stream

Germany is the first commercial launch market for DAYBU in Europe, following the European authorisation reported in August. The launch triggered the US$35 million first-sale payment, which had been anticipated in coverage of the European DAYBU approval but is now reflected in Neuren’s 2026 income outlook.

Under the European licence, Neuren is entitled to tiered royalties of 17%, 20% and 23% on the applicable portions of annual net sales, with sales milestones beginning at US$120 million and rising to US$75 million at US$600 million. Each sales milestone is payable once. The announcement does not provide a European sales forecast, leaving the timing of further milestones dependent on market uptake across the territory.

Patent protection and Japan programme extend the runway

Acadia has also received allowance for a US patent covering weight-banded trofinetide dosing. Neuren said the patent extends protection for DAYBUE and DAYBUE STIX by nearly five years, through March 2041, building on the earlier weight-banded dosing patent.

In Japan, Acadia has completed a Phase 3 Rett syndrome study whose results were described as consistent with the LAVENDER Phase 3 study and supportive of a planned regulatory submission in 2027. Acadia is seeking a distribution partner ahead of that filing, with a potential launch in 2028 subject to regulatory approval. Those dates remain targets rather than secured commercial milestones, and the immediate earnings upgrade still rests primarily on US sales and the new European launch.